Liver Cancer, Liver Metastases, Opioid Use, Postoperative Pain
Conditions
Keywords
liver surgery, postoperative pain, Lidocaine, opioid use
Brief summary
This is a randomized double blinded placebo-controlled study, conducted in Lund, Sweden. Patients will be randomized in two groups, with a ratio of 1:1. The experimental arm will receive intravenous Lidocaine perioperatively, and the Control arm will receive placebo, i.e. normal Saline. Postoperative both arms will get routine pain Control with PCA, Patient Controlled Analgesia with an intravenous Oxycodone-infusion. Outcome-measures will include patients pain intensity scoring, and opioid consumption.
Detailed description
Patientes will be randozied in blocks of eight. The experimental arm will receive a bolus of 1,5mg/kg before induction of anesthesia, immediately followed by an infusion of 1,5mg/kg/h until 1 hour post surgery. The placebo arm will receive the same amount of normal Saline instead. Pain intensity scoring, measured by Numerical Rating Scale, NRS, will be conducted at 1, 2, 4 hour postoperatively, and each morning and night until discharge, or for a maximum 5 Days.
Interventions
DRUGLidocaine
Intravenous perioperative Lidocain for pain Control and improvement of postoperative recovery
DRUGNormal saline
Placebo
Sponsors
Lund University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized double blinded placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 yy * Patient planned for minor hepatectomy * Signed informed consent
Exclusion criteria
* Pregnancy * Cirrosis * ASA\>3 * Elevated liver enzymes * AV-block \>1, without pacemaker * WHO class \>2 * Allergy against Lidocain or other amid-type local anasthesia * Heart failure * Epilepsy * Treatment with class III anti-arythimic medication * Preoperative ongoing opioid usage * Use of : Erythromycin, clarithromycin, Fluvoxamine, Cimetidine, ciprofloxacin, antivirala-HIV-läkemedel or imidazol the week before surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption at 24 hours | 24 hours postoperatively | Sum of opioids consumed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption at 48 hours | 48 hours postoperatively | Sum of opioids consumed |
| Opioid consumption at 72 hours | 72 hours postoperatively | Sum of opioids consumed |
| Opioid consumption at 96 hours | 96 hours postoperatively | Sum of opioids consumed |
| Opioid consumption at 120 hours | 120 hours postoperatively | Sum of opioids consumed |
| Postoperative pain intensity | Day 0-5 postoperatively, twice every day | Numerical rating scale (NRS) in rest and activity, scale 0-10, 0=no pain, 10=worst imaginable pain |
| Number of participants with Postoperative comlications | 30 days postoperatively | Comparition of Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4,5 |
| Level of Postoperative comlications | 30 days postoperatively | Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4a,4b,5, 0 beeing none and 5 beeng death. |
| Time to return of Bowel function | Day 0-30 postoperatively | Time to first flatus and defacation |
| Number of participants with Postoperative nausea and vomiting | Day 1-5 postopertively | Postoperative nausea and vomiting, as noted in questionary Quality of recovery-40 |
| Level of adverse events | 0-30 days | All adverse events, classified according to CTCEA |
| Days in hospital | 0-90 days postoperatively | Length of hospital stay |
| Level of MEGX concentrations | Twice during surgery, and once 1 hour after surgery. | Concentration of the metabolite MEGX in patients blood |
| Level of Lidocaine concentration | Twice during surgery, and once 1 hour after surgery. | Concentration of Lidocaine in patients blood |
| Mortality | 30 days postoperatively | death after surgery |
| Rating of Quality of recovery-40 | Day 1-5 postoperatively | Quality of recovery questionary. |
| Number of participant with Adverse Events | 0-30 days | All adverse events |
| Number of participants with Chronic Postsurgical pain | 3 months after surgery | Chronic Postsurgical pain, according to Brief Pain inventory- questionary |
| Level of Chronic Postsurgical pain | 3 months after surgery | Chronic Postsurgical pain, according to Brief Pain inventory- questionary |
| Level of Postoperative nausea and vomiting | Day 1-5 postopertively | Postoperative nausea and vomiting, as noted in questionary Quality of recovery-40 |
Countries
Sweden
Outcome results
None listed